Tags: US | Congress | EpiPen | The Latest

FDA Questioned on Generic Alternatives to EpiPen

FDA Questioned on Generic Alternatives to EpiPen

(Joe Readle, Getty Images)

Wednesday, 21 September 2016 03:56 PM EDT

A senior Food and Drug Administration official says the agency cannot approve generic versions of EpiPen if manufacturers do not submit them.

The FDA's Dr. Douglas Throckmorton told House lawmakers that his agency has given the drug industry suggestions for developing drug injectors like EpiPen.

Lawmakers have pressed the FDA in recent days on what can be done to create more competition for Mylan's EpiPen.

The agency has a backlog of generic drugs under review, including a version of EpiPen from competitor Teva Pharmaceuticals.

But the company said earlier this year that regulators had found problems with its application. Teva's drug and several others aren't expected to hit the market until 2017 or later.

The head of pharmaceutical company Mylan defended the cost for life-saving EpiPens, signaling the company has no plans to lower prices despite a public outcry and questions from skeptical lawmakers.

In testimony for Congress, CEO Heather Bresch said Wednesday she believes Mylan has struck a balance between price and access to the drug. The price of EpiPens has grown to $608 for a two-pack, an increase of more than 500 percent since 2007.

Bresch said the company does not want to go back to a time when awareness of allergic reactions was much lower and many schools did not stock the drug.

The House Oversight and Government Reform Committee questioned Bresch about the pricing.

© Copyright 2026 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


Health-News
A senior FDA official says the agency cannot approve generic versions of EpiPen if manufacturers do not submit them, in testimony before Congress.
US, Congress, EpiPen, The Latest
228
2016-56-21
Wednesday, 21 September 2016 03:56 PM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved